SRS (Stereotactic Radiosurgery) Plus Ipilimumab
| Status: | Suspended |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
A Pilot Study of Stereotactic Radiosurgery Combined With Ipilimumab in Patients With Newly Diagnosed Melanoma Metastases in the Brain and Spine
This research is being done to look at the safety of using stereotactic radiosurgery (SRS)
and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both
Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of
care uses both of these treatments but not together. By using them together, we expect
better treatment of melanoma, but there might be an increase in side effects.
"Ipilimumab" is approved by the Food and Drug Administration (FDA) for the treatment of
melanoma that has spread throughout the body. It works by activating your immune system to
fight off cancer.
"Stereotactic radiosurgery" (SRS) is approved by the Food and Drug Administration (FDA) for
the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without
needing to cut or use stitches.
The use of combining SRS and Ipilimumab in this research study is investigational. The word
"investigational" means that this combination is not approved for marketing by the Food and
Drug Administration but is allowed for use in this research study.
and Ipilimumab together to treat melanoma that has spread to the brain or spine. Both
Ipilimumab and SRS are used alone for the treatment of melanoma that has spread. Standard of
care uses both of these treatments but not together. By using them together, we expect
better treatment of melanoma, but there might be an increase in side effects.
"Ipilimumab" is approved by the Food and Drug Administration (FDA) for the treatment of
melanoma that has spread throughout the body. It works by activating your immune system to
fight off cancer.
"Stereotactic radiosurgery" (SRS) is approved by the Food and Drug Administration (FDA) for
the treatment of melanoma in the brain or spine. It uses radiation to treat tumors without
needing to cut or use stitches.
The use of combining SRS and Ipilimumab in this research study is investigational. The word
"investigational" means that this combination is not approved for marketing by the Food and
Drug Administration but is allowed for use in this research study.
Inclusion Criteria:
1. Patients must have histologically confirmed diagnosis of melanoma. The pathologic
confirmation may be from another metastatic site or from metastatic brain or spine
lesions.
2. Patients must have Stage IV melanoma, with newly identified brain or spine
metastases.
3. Patients must have measurable lesion in the brain or spine that is > 3 mm seen on
magnetic resonance imaging (MRI) with contrast.
NOTE: Contrasted pre-treatment MRI scan must be obtained ≤ 21 days prior to
stereotactic radiosurgery treatment.
4. Karnofsky Performance Scale >70%
5. Patients must have normal organ and marrow function as defined below:
leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL platelets >100,000/mcL
total bilirubin ≤2X institutional upper limit of normal AST(SGOT)/ALT(SGPT) <2.5 X
institutional upper limit of normal creatinine within normal institutional limits OR
According to Johns Hopkins MRI policy
6. Women of child bearing potential (WOCBP) using a reliable form of contraception
during the study treatment period and for up to 12 weeks following the last dose of
study drug [21].
7. Men must agree to the use of male contraception during the study treatment period and
for at least 12 weeks after the last dose of study drug.
8. Ability to understand and the willingness to sign written informed consent
document(s).
Exclusion Criteria:
1. Prior whole brain radiation or conventional radiation to the spine at the site of new
lesion.
2. Prior chemotherapy within 28 days of starting treatment.
3. Prior therapy with investigational drugs within 28 days or at least 5 half-lives
(whichever is longer) before study administration.
4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody.
5. Neurologic dysfunction that would confound the evaluation of neurologic and other
adverse events.
6. Known allergy to compounds of similar chemical or biologic composition to ipilimumab.
7. Pregnant or breastfeeding women.
8. Known history of Human Immunodeficiency Virus.
9. Active infection requiring therapy, positive tests for Hepatitis B surface antigen or
Hepatitis C ribonucleic acid (RNA) [11].
10. Active autoimmune disease, history of autoimmune disease or history of syndrome that
required systemic steroids or immunosuppressive medications. Exceptions include those
with vitiligo or resolved childhood asthma/atopy. Subjects with asthma who require
intermittent use of bronchodilators (such as albuterol) will not be excluded from
this study [11].
11. Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up
to 4 weeks (28 days) before receiving ipilimumab.
12. Prisoners or subjects who are compulsorily detained for treatment of either a
psychiatric or physical (e.g. infectious disease) illness.
13. Patients with both brain and spine metastases will be excluded from the trial.
14. Patients who are allergic to MRI contrast agent or have contraindication for MRI.
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